Virtual RealityNCT03686176
Virtual Reality During Procedures in Pediatric Patients
A study testing Virtual Reality in people with Virtual Reality and Pediatrics, run by Johns Hopkins University at 1 site in United States.
Trial summary
This stratified, randomized, controlled trial compared coping and distress between child life supported virtual reality engagement and child life support during painful procedures in the pediatric emergency department. Read more about this study
- Who is it for?
- Ages 7 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Pediatrics
- What is being tested?
- Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2019to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pediatric patients requiring painful or anxiety inducing procedures:
- Burn debridement
- Burn dressing change
- Lactation repair
- Intravenous (IV) line placement or phlebotomy (blood draw)
- Abscess incision and drainage
Show all 10Show fewer
- Fracture reduction and/or cast placement
- Implanted central venous port placement accessing
- Skin biopsies
- Subjects ages 7 to 26 years of age (age 26 is the upper limit treated at JHCC) Ages were chosen based on that previously published in the literature on pediatric patients with VR.
Who cannot join
- Patients with a known history of a seizure disorder.
- Patients with an active infection, burn, or trauma that interferes with the mask placement, and may include involvement of the periorbital skin, eyes, nasal bridge, external ear, and/or scalp or hair.
- Patients with Blindness.
- Developmental delay significant enough to interfere with the subject's ability to participate in the session, including autism spectrum disorders.
- Patients with active psychosis or exhibit signs of active intoxication.
- Known history of severe motion sickness
Show all 9Show fewer
- Medical urgency (at the medical providers' discretion)
- Non-verbal children
- Children or parents/legal guardians who are non-English speakers
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Children's Center
Baltimore, Maryland, 21212
About this study
This stratified, randomized, controlled trial compared coping and distress between child life supported virtual reality engagement and child life support during painful procedures in the pediatric emergency department.
Read the detailed description
Pediatric emergency rooms and hospitals are anxiety provoking and often painful places for pediatric patients and families. Children of all ages present to the Johns Hopkins emergency room and are admitted to the hospital for a wide range of medical conditions, many of which require medical interventions. Many of these interventions are the source of anxiety and pain, including burn debridement or dressing changes, laceration repair, or intravenous (IV) line placement. The standard of care to reduce pain and improve coping during pediatric procedures ranges from no intervention to support from child life specialists.
As an adjunct to the existing methods of promoting comfort during painful procedures, non-invasive virtual reality (VR) therapy is showing promise as a means of distraction and coping with various medical procedures. The user is transported into a relaxing/distracting VR environment that diverts user's attention away from pain and anxiety. VR has demonstrated efficacy in the reduction of pain and anxiety experienced by individuals undergoing anxiety and pain inducing procedures.While there is early data from small or narrow populations that show some improvement in pain and anxiety with VR use during pediatric procedures, some studies show no improvement. No studies to date have used objective outcome measures of coping, which may be more clinically meaningful.
The investigators propose to fill this gap in the literature with a randomized, controlled, un-blinded study of coping and distress between virtual reality engagement and child life support in pediatric patients undergoing painful medical procedures.
- Conditions
- Virtual Reality, Pediatrics
- Being tested
- Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
Also called Oculus Go
A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group (Study Group) | Experimental | In this arm, patients will receive support from child life specialists plus may use virtual reality simulation goggles during a qualifying medical procedure. Receives: Other: Virtual Reality |
| Active Control Group | No intervention | In this arm, patients will receive standard of care with child life specialists plus distraction of the child's choosing, during a qualifying medical procedure. |
| External Control (Reference Group) | No intervention | No virtual reality and no child life specialists; no standardized or formal form of support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient-Reported Pain During the Procedure
Pain described on visual analog scale (0-10), or Wong-Faces Scale (0-10) with 0 being no pain and 10 being worst pain. Change in pain scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced pain during the procedure.
Measured: Baseline and Immediately post-procedure, up to 15 minutes
Change in Patient-Reported Anxiety During Procedure
Patient anxiety after procedures was described on a visual analog scale (0-10). This is a scale of range 0-10 with 0 being no anxiety and 10 being maximum anxiety. Change in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure.
Measured: Baseline and Immediately post-procedure, up to 15 minutes
Change in Adult Perceived Pain During the Procedure
Perceived pain ratings were obtained for caregivers after the procedure based on a 0-10 Likert rating scale with 0 representing the least pain and 10 representing the most. Change in pain scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced pain during the procedure. This measure was assessed in caregivers.
Measured: Baseline and Immediately post-procedure, up to 15 minutes
Change in Adult Perceived Anxiety During the Procedure
The Subjective Units of Distress scale will be used to measure anxiety of subjects after procedures. This is a scale of 0-10 with 0 being no anxiety and 10 being maximum anxiety. Change in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure. This measure was assessed in caregivers.
Measured: Baseline and Immediately post-procedure, up to 15 minutes
Change in Adult's Own Anxiety During the Procedure
Anxiety ratings were obtained for caregivers after the procedure based on a 0-10 Likert rating scale with 0 representing the least anxiety and 10 representing the most. Change in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure. This measure was assessed in caregivers.
Measured: Baseline and Immediately post-procedure, up to 15 minutes
Child and Adult Medical Procedure Interaction Scale (CAMPIS) Score
Coping was measured using a modified CAMPIS-SF in both patients and caregivers.
CAMPIS-SF (Child-Adult Medical Procedure Interaction Scale-Short Form) is a behavior rating scale that documents distressing or coping behaviors exhibited in both children and the accompanying adult (parent/guardian). It has been validated to measure coping in children and adults during medical procedures. The CAMPIS-SF study used a 5-point Likert scale to document frequency of each code In order to account for frequency variance due to differences in procedure duration, we used a proportion-based metric validated for CAMPIS-R, and applied this to CAMPIS-SF codes. Proportions were calculated by summing the total number of an event type (e.g. child distress) and dividing by the total number of coded events (child distress plus child coping). This provided a proportion for each event type so that the proportion of child distress plus child coping events add up to 1.0 (range 0-1.0).
Measured: Immediately post-procedure, up to 15minutes
Secondary outcomes (6)
Duration of Procedure
Duration of procedure in minutes will be assessed for each procedure.
Measured: Immediately post-procedure, up to 20 minutes
Ease of Procedure as Assessed by a Likert Scale
Ease of procedure will be assessed using a Likert scale completed by proceduralist. The Likert scale ranges from 0-10 with 0 being easy and 10 difficult.
Measured: Immediately post-procedure, up to 15 minutes
Personnel Use for Immobilization
This will be assessed using number of patients requiring immobilization during procedures.
Measured: Immediately post-procedure, up to 15 minutes
Number of IV or Phlebotomy Attempts
Number of IV or phlebotomy attempts until success will be counted (1 or 2+) in patients undergoing venipuncture procedures.
Measured: Immediately post-procedure, up to 15 minutes
Pre-Procedure Nausea Symptoms
The number of patients reporting nausea symptoms prior to the procedure
Measured: Immediately pre-procedure (15minutes)
Pre-Procedure Cybersickness Symptoms
Number of patients in the VR group reporting positive cybersickness symptoms prior to the procedure
Measured: Immediately pre-procedure (15minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start5 Jul 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Why it stopped: Coronavirus (COVID-19)-related pause on all clinical research studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, unblinded, controlled
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- The Thomas Wilson Sanitarium for Children of Baltimore City
- Responsible party
- Sponsor
- Investigators
- Therese Canares, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686176
- Sponsor's protocol ID
- IRB00161331
- Status last verified
- Jul 2020
- First submitted
- 25 Sep 2018
- Last updated
- 6 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Canares T, Parrish C, Santos C, Badawi A, Stewart A, Kleinman K, Psoter K, McGuire J. Pediatric Coping During Venipuncture With Virtual Reality: Pilot Randomized Controlled Trial. JMIR Pediatr Parent. 2021 Jul 28;4(3):e26040. doi: 10.2196/26040.
PubMed 34319249Canares TL, Parrish C, Santos C, Badawi A, Stewart A, Kleinman K, Psoter KJ, McGuire JF. Resource Use During Pediatric Venipuncture With Virtual Reality: Secondary Analysis of a Randomized Controlled Pilot Trial. Hosp Pediatr. 2021 Jul;11(7):775-778. doi: 10.1542/hpeds.2020-003822. Epub 2021 Jun 14.
PubMed 34127486
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality During Procedures in Pediatric Patients
- ClinicalTrials.gov ID
- NCT03686176
- Acronym / sponsor ID
- IRB00161331
- Conditions
- Virtual Reality, Pediatrics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Coronavirus (COVID-19)-related pause on all clinical research studies.
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- The Thomas Wilson Sanitarium for Children of Baltimore City
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 26 Sep 2018 (actual)
- Results
- Posted 28 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This stratified, randomized, controlled trial compared coping and distress between child life supported virtual reality engagement and child life support during painful procedures in the pediatric emergency department.
Detailed description
Pediatric emergency rooms and hospitals are anxiety provoking and often painful places for pediatric patients and families. Children of all ages present to the Johns Hopkins emergency room and are admitted to the hospital for a wide range of medical conditions, many of which require medical interventions. Many of these interventions are the source of anxiety and pain, including burn debridement or dressing changes, laceration repair, or intravenous (IV) line placement. The standard of care to reduce pain and improve coping during pediatric procedures ranges from no intervention to support from child life specialists.
As an adjunct to the existing methods of promoting comfort during painful procedures, non-invasive virtual reality (VR) therapy is showing promise as a means of distraction and coping with various medical procedures. The user is transported into a relaxing/distracting VR environment that diverts user's attention away from pain and anxiety. VR has demonstrated efficacy in the reduction of pain and anxiety experienced by individuals undergoing anxiety and pain inducing procedures.While there is early data from small or narrow populations that show some improvement in pain and anxiety with VR use during pediatric procedures, some studies show no improvement. No studies to date have used objective outcome measures of coping, which may be more clinically meaningful.
The investigators propose to fill this gap in the literature with a randomized, controlled, un-blinded study of coping and distress between virtual reality engagement and child life support in pediatric patients undergoing painful medical procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized, unblinded, controlled
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group (Study Group) | Experimental | Other: Virtual RealityIn this arm, patients will receive support from child life specialists plus may use virtual reality simulation goggles during a qualifying medical procedure. |
| Active Control Group | No intervention | –In this arm, patients will receive standard of care with child life specialists plus distraction of the child's choosing, during a qualifying medical procedure. |
| External Control (Reference Group) | No intervention | –No virtual reality and no child life specialists; no standardized or formal form of support. |
Who may qualify
- Ages
- 7 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Pediatric patients requiring painful or anxiety inducing procedures:
- Subjects ages 7 to 26 years of age (age 26 is the upper limit treated at JHCC) Ages were chosen based on that previously published in the literature on pediatric patients with VR.
Key exclusion criteria (9 listed)
- Patients with a known history of a seizure disorder.
- Patients with an active infection, burn, or trauma that interferes with the mask placement, and may include involvement of the periorbital skin, eyes, nasal bridge, external ear, and/or scalp or hair.
- Patients with Blindness.
- Developmental delay significant enough to interfere with the subject's ability to participate in the session, including autism spectrum disorders.
- Patients with active psychosis or exhibit signs of active intoxication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityAlso: Oculus GoA child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins. | Other | Virtual Reality Group (Study Group) |
Primary outcome
Change in Patient-Reported Pain During the Procedure
Time frame: Baseline and Immediately post-procedure, up to 15 minutes
Pain described on visual analog scale (0-10), or Wong-Faces Scale (0-10) with 0 being no pain and 10 being worst pain. Change in pain scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced pain during the procedure.
Change in Patient-Reported Anxiety During Procedure
Time frame: Baseline and Immediately post-procedure, up to 15 minutes
Patient anxiety after procedures was described on a visual analog scale (0-10). This is a scale of range 0-10 with 0 being no anxiety and 10 being maximum anxiety. Change in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure.
Change in Adult Perceived Pain During the Procedure
Time frame: Baseline and Immediately post-procedure, up to 15 minutes
Perceived pain ratings were obtained for caregivers after the procedure based on a 0-10 Likert rating scale with 0 representing the least pain and 10 representing the most. Change in pain scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced pain during the procedure. This measure was assessed in caregivers.
Change in Adult Perceived Anxiety During the Procedure
Time frame: Baseline and Immediately post-procedure, up to 15 minutes
The Subjective Units of Distress scale will be used to measure anxiety of subjects after procedures. This is a scale of 0-10 with 0 being no anxiety and 10 being maximum anxiety. Change in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure. This measure was assessed in caregivers.
Change in Adult's Own Anxiety During the Procedure
Time frame: Baseline and Immediately post-procedure, up to 15 minutes
Anxiety ratings were obtained for caregivers after the procedure based on a 0-10 Likert rating scale with 0 representing the least anxiety and 10 representing the most. Change in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure. This measure was assessed in caregivers.
Child and Adult Medical Procedure Interaction Scale (CAMPIS) Score
Time frame: Immediately post-procedure, up to 15minutes
Coping was measured using a modified CAMPIS-SF in both patients and caregivers. CAMPIS-SF (Child-Adult Medical Procedure Interaction Scale-Short Form) is a behavior rating scale that documents distressing or coping behaviors exhibited in both children and the accompanying adult (parent/guardian). It has been validated to measure coping in children and adults during medical procedures. The CAMPIS-SF study used a 5-point Likert scale to document frequency of each code In order to account for frequency variance due to differences in procedure duration, we used a proportion-based metric validated for CAMPIS-R, and applied this to CAMPIS-SF codes. Proportions were calculated by summing the total number of an event type (e.g. child distress) and dividing by the total number of coded events (child distress plus child coping). This provided a proportion for each event type so that the proportion of child distress plus child coping events add up to 1.0 (range 0-1.0).
6 secondary outcomes
Duration of Procedure
Time frame: Immediately post-procedure, up to 20 minutes
Ease of Procedure as Assessed by a Likert Scale
Time frame: Immediately post-procedure, up to 15 minutes
Personnel Use for Immobilization
Time frame: Immediately post-procedure, up to 15 minutes
Number of IV or Phlebotomy Attempts
Time frame: Immediately post-procedure, up to 15 minutes
Pre-Procedure Nausea Symptoms
Time frame: Immediately pre-procedure (15minutes)
Pre-Procedure Cybersickness Symptoms
Time frame: Immediately pre-procedure (15minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34319249Canares T, Parrish C, Santos C, Badawi A, Stewart A, Kleinman K, Psoter K, McGuire J. Pediatric Coping During Venipuncture With Virtual Reality: Pilot Randomized Controlled Trial. JMIR Pediatr Parent. 2021 Jul 28;4(3):e26040. doi: 10.2196/26040.
- Derived from this study: PubMed 34127486Canares TL, Parrish C, Santos C, Badawi A, Stewart A, Kleinman K, Psoter KJ, McGuire JF. Resource Use During Pediatric Venipuncture With Virtual Reality: Secondary Analysis of a Randomized Controlled Pilot Trial. Hosp Pediatr. 2021 Jul;11(7):775-778. doi: 10.1542/hpeds.2020-003822. Epub 2021 Jun 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Therese Canares, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Virtual Reality and Pediatrics, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient-Reported Pain During the Procedure (time frame: Baseline and Immediately post-procedure, up to 15 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03686176, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.